(45 days)
Not Found
No
The device is a calibration verification test set for chemistry systems, and the description focuses on chemical composition and performance metrics like linear regression and correlation coefficient, with no mention of AI or ML.
No.
The device is an in vitro diagnostic (IVD) test set intended for verifying calibration and validating reportable ranges in chemistry systems, not for treating diseases or conditions.
No
The device is a calibration verification test set used to verify calibration, validate reportable ranges, and determine linearity in chemistry systems, not to diagnose a medical condition in a patient.
No
The device description clearly states it contains "purified chemicals in an aqueous base" and is provided in "bottles," indicating a physical, chemical-based product, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the device is "intended for in vitro diagnostic use".
- Function: The device is used to verify the calibration and linearity of chemistry systems, which are used to perform diagnostic tests on patient samples (even though the device itself is not directly applied to a patient). This process is a crucial part of ensuring the accuracy of diagnostic results.
- Analytes: The device is designed to work with specific analytes (sodium, potassium, chloride, etc.) that are commonly measured in clinical diagnostic tests.
- User and Setting: The intended users are "trained laboratory professionals" and the setting is "automated, semi-automated and manual chemistry systems," which are typical for clinical diagnostic laboratories.
Therefore, based on the provided information, the VALIDATE Chem 1 Calibration Verification Test Set clearly fits the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
VALIDATE Chem 1 Calibration Verification Test Set is intended for in vitro diagnostic use for quantitatively verifying calibration, validating reportable ranges, and determining linearity in automated, semi-automated and manual chemistry systems for the following analytes: sodium, potassium, chloride, calcium, phosphorus, lactate, glucose, urea nitrogen, creatinine, triglyceride, ammonia, ethanol, magnesium, and lithium.
The VALIDATE Chem 1 Calibration Verification Test Set is used by trained laboratory professionals for quantitatively verifying calibration, validating reportable ranges, and determining linearity in automated, semi-automated and manual chemistry systems for the following analytes: sodium, potassium, chloride, calcium, phosphorus, lactate, glucose, urea nitrogen, creatinine, triglyceride, ammonia, ethanol, magnesium, and lithium.
Product codes (comma separated list FDA assigned to the subject device)
JJY
Device Description
VALIDATE Chem 1 Calibration Verification Test Set contains purified chemicals in an aqueous base. Multiple levels are provided to establish the relationship between theoretical operation and actual performance of each of the included analytes. Each set contains one bottle each of six (6) levels, including zero. Each bottle contains 5 milliliters.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained laboratory professionals / automated, semi-automated and manual chemistry systems
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Linear regression analysis was carried out on recovered values for each analyte. Each analyte was tested in triplicate. The VALIDATE Chem 1 Calibration Verification Test Set has been shown to be functionally equivalent for calibration and linearity assessment to DOCUMENT Multi-Analyte CALVER, DOCUMENT Direct ISE CALVER DOCUMENT Iron, Magnesium, Triglyceride CAL.VER, DOCUMENT Ammonia/Ethanol CAL. VER, and Roche Diagnostics Precitrol Ethyl Alcohol/ Ammonia/Lactate Control.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Correlation Coefficient (r) and Regression Equation (Y=intercept + slope(X)) for various analytes.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K870252, K881773, K893142, K962629
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
0
510(k) SUMMARY
"This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92."
"The assigned 510(k) number is: KO12117
| Submitter: | Maine Standards Company |
|---|---|
| Address: | 765 Roosevelt Trail |
| Windham, ME 04062 | |
| Telephone: | 207-892-1300 |
| Fax: | 207-892-2266 |
| Contact: | Christine Beach, Mgr. RA/QA |
Summary prepared on: June 29, 2001
| Proprietary Name: | VALIDATE Chem 1 Calibration Verification Test Set |
|---|---|
| Common Name: | Calibration Verification |
| Classification Name: | Calibrator, Multi-Analyte |
Predicate Devices:
- DOCUMENT Multi-Analyte CAL-VER, K870252, manufactured by 1. CASCO NERL Diagnostics.
-
- DOCUMENT Direct ISE CAL-VER, K881773, manufactured by CASCO NERL Diagnostics.
- DOCUMENT Iron/Magnesium/Triglyceride CAL-VER, K893142, ని. manufactured by CASCO NERL Diagnostics.
- DOCUMENT Ammonia/Ethanol CAL-VER, K962629, manufactured by বাঁ CASCO NERL Diagnostics.
- Precitrol Ethyl Alcohol/Ammonia/Lactate Control, Roche Diagnostics. ട്.
Device description: VALIDATE Chem 1 Calibration Verification Test Set contains purified chemicals in an aqueous base. Multiple levels are provided to establish the relationship between theoretical operation and actual performance of each of the included analytes. Each set contains one bottle each of six (6) levels, including zero. Each bottle contains 5 milliliters.
Intended use: VALIDATE Chem 1 Calibration Verification Test Set is intended for in vitro diagnostic use for quantitatively verifying calibration, validating reportable ranges, and determining linearity in automated, semi-automated and manual chemistry systems for the following analytes: sodium, potassium, chloride, calcium, phosphorus, lactate, glucose, urea nitrogen, creatinine, triglyceride, ammonia, ethanol, magnesium, and lithium.
Office location . 765 Roosevelt Trail . Windham, Maine 04062 Mailing address • P.O. Box 8360 • Portland, ME 04104-8360 Tel. 207.892.1300 ・ Fax 207.892.2266 ・ Toll Free 800.377.9684
1
Comparison of VALIDATE Chem 1 Calibration Verification Test Set to the predicate devices:
Table 1 compares characteristics of the VALIDATE Chem 1 Calibration Verification Test Set with those of the DOCUMENT Multi-Analyte CAL•VER, DOCUMENT Direct ISE CAL•VER, DOCUMENT Iron, Magnesium, Triglyceride CAL•VER, DOCUMENT Ammonia/Ethanol CAL•VER, and Roche Diagnostics Precitrol Ethyl Alcohol/Ammonia/Lactate Control.
| | VALIDATE
CHEM 1
Calibration
Verification Test
Set | DOCUMENT
Multi-Analyte
CAL·VER | DOCUMENT
Direct ISE
CAL·VER | DOCUMENT
Iron,
Magnesium,
Triglyceride
CAL·VER |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Catalog # | 10001 | M-100 | M-101 | M-103 |
| Intended Use | For in vitro
diagnostic use in
quantitatively
verifying
calibration,
validating
reportable
ranges, and
determining
linearity in
automated, semi-
automated and
manual chemistry
systems. | For in vitro
diagnostic use in
the quantitative
determination of
linearity in
manual,
automated and
semi-automated
chemistry
systems. | For in vitro
diagnostic use in
the quantitative
determination of
linearity in
manual,
automated and
semi-automated
chemistry
systems. | For in vitro
diagnostic use in
the quantitative
determination of
linearity in
manual,
automated and
semi-automated
chemistry
systems. |
| Analytes | NA, K, CL, CA,
PO₄, GLU, BUN,
CRE, TRIG, MG,
LAC, NH₃
ETOH, LI | GLU, BUN, NA,
K, CL, CRE, CA,
PO₄ | NA, K, CL, LI | MG
TRIG |
| Matrix | aqueous | aqueous | aqueous | aqueous |
| Number of
Levels | 6 including Zero | 5 | 5 | 5 |
| Preparation | Liquid,
ready to use | Liquid,
ready to use | Liquid,
ready to use | Liquid,
ready to use |
| Packaging | 5.0 mL each level | 15.0 mL each
level | 10.0 mL each
level | 10.0 mL each
level |
| Stability | Until Expiration | Until Expiration | Until Expiration | Until Expiration |
| Storage | 2-8°C | 18-25°C | 18-25°C | 2-8°C |
Comparison of Products TABLE 1.
2
TABLE 1: continued
| | VALIDATE CHEM 1
Calibration
Verification Test Set | DOCUMENT
Ammonia/
Ethanol
CAL·VER | Roche Diagnostics
Precitrol Ethyl
Alcohol/Ammonia/
Lactate Controls
Low and High |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Catalog # | 10001 | M-100 | 1775812 / 1775782 |
| Intended Use | For in vitro diagnostic
use in quantitatively
verifying calibration,
validating reportable
ranges, and determining
linearity in automated,
semi-automated and
manual chemistry
systems. | For in vitro diagnostic
use in the quantitative
determination of
linearity in manual,
automated and semi-
automated chemistry
systems. | For use as an
assayed control
material to aid in the
assessment of day-
to-day performance
of automated, semi-
automated or
manual chemistry
systems. |
| Analytes | NA, K, CL, CA, PO4,
GLU, BUN, CRE, TRIG,
MG, LAC, NH3
ETOH, LI | NH3
ETOH | LAC |
| Matrix | aqueous | aqueous | aqueous |
| Number of
Levels | 6 including Zero | 5 | 1 low and 1 high |
| Preparation | Liquid,
ready to use | Liquid,
ready to use | Liquid,
ready to use |
| Packaging | 5.0 mL each level | 3.0 mL each level | 4.0 mL each level |
| Stability | Until Expiration | Until Expiration | Until Expiration |
| Storage | 2-8°C | 2-8°C | 2-8°C |
The performance of VALIDATE Chem 1 Calibration Verification Test Set solutions on the Roche Diagnostics Hitachi 911 instrument system as compared to DOCUMENT Multi-Analyte CAL•VER, DOCUMENT Direct ISE CAL•VER, DOCUMENT Iron, Magnesium, Triglyceride CAL•VER, DOCUMENT Ammonia/Ethanol CAL•VER, and Roche Diagnostics Precitrol Ethyl Alcohol/Ammonia/Lactate Control has been shown to be substantially equivalent using pre-production lots of VALIDATE Chem 1 Calibration Verification Test Set. The results of correlation comparisons between the VALIDATE Chem 1 Calibration Verification Test Set and the predicate devices are presented in Table 2.
3
| | VALIDATE
Chem 1
Calibration
Verification Test Set | | DOCUMENT
Multi-Analyte
CAL·VER | | DOCUMENT
Direct ISE
CAL·VER | | DOCUMENT
Iron, Magnesium,
Triglyceride
CAL·VER | |
|---------|------------------------------------------------------------|-----------------------------------------------------|--------------------------------------|-----------------------------------------------------|-----------------------------------|-----------------------------------------------------|---------------------------------------------------------|---------------------------------------------------|
| Analyte | Correlation
Coefficient
(r) | Regression
Equation
Y=intercept
- slope(X) | Correlation
Coefficient
(r) | Regression
Equation
Y=intercept - slope(X) | Correlation
Coefficient
(r) | Regression
Equation
Y=intercept - slope(X) | Correlation
Coefficient
(r) | Regression
Equation
Y=intercer - slope{X |
| NA | 0.99993 | -2.455 +
1.017 | N/A | N/A | 0.99976 | 3.02 +
.966 | N/A | N/A |
| K | 0.99964 | -.014 +
1.018 | N/A | N/A | 0.99983 | -.014 +
.98 | N/A | N/A |
| CL | 0.99998 | -.175 +
1.002 | N/A | N/A | 0.99972 | -3.751 +
1.017 | N/A | N/A |
| CA | 0.99992 | -.017 +
1.007 | 0.99995 | -.609 +
1.124 | N/A | N/A | N/A | N/A |
| PO4 | 0.99999 | -.048 +
1.011 | 0.99985 | -.167 +
1.049 | N/A | N/A | N/A | N/A |
| GLU | 0.99998 | -.486 +
.998 | 0.99994 | 2.529 +
1.02 | N/A | N/A | N/A | N/A |
| BUN | 0.99998 | -.729 +
1.016 | 0.99972 | 1.836 +
.924 | N/A | N/A | N/A | N/A |
| CRE | 0.99999 | -.066 +
1.005 | 0.99997 | -.32 +
1.063 | N/A | N/A | N/A | N/A |
| TRIG | 0.99999 | -3.002 +
1.004 | N/A | N/A | 0.99997 | 1.58 +
1.016 | 0.99997 | 1.58 +
1.016 |
| MG | 0.99984 | .022 +
.992 | N/A | N/A | 0.99913 | .138 +
1.009 | 0.99913 | .138 +
1.009 |
| LI | 0.99978 | .074 +
.982 | 0.99959 | -.052 +
.986 | N/A | N/A | N/A | N/A |
Linear Regression Statistical Comparison of VALIDATE Chem 1 TABLE 2. Calibration Verification Test Set to the predicate devices.
TABLE 2: continued
| VALIDATE
Chem 1
Calibration Verification Test
Set | | DOCUMENT
Ammonia/
Ethanol
CAL·VER | | Roche Diagnostics
Precitrol Ethyl
Alcohol/Ammonia/Lactate
Control Low and High | | |
|------------------------------------------------------------|-----------------------------------|-----------------------------------------------------|-----------------------------------|-----------------------------------------------------------------------------------------|-----------------------------------|-----------------------------------------------------|
| Analyte | Correlation
Coefficient
(r) | Regression
Equation
Y=intercept +
slope(X) | Correlation
Coefficient
(r) | Regression
Equation
Y=intercept +
slope(X) | Correlation
Coefficient
(r) | Regression
Equation
Y=intercept +
slope(X) |
| LAC | 0.99995 | .046 + .979 | N/A | N/A | 0.99990 | -.049 + 1.00 |
| NH3 | 0.99498 | 29.859 + .905 | 0.99945 | 10.778 + .915 | N/A | N/A |
| ETOH | 0.99948 | 2.281 + .965 | 0.99992 | 1.609 + .971 | N/A | N/A |
Summary:
Linear regression analysis was carried out on recovered values for each analyte. Each analyte was tested in triplicate. The VALIDATE Chem 1 Calibration Verification Test Sei has been shown to be functionally equivalent for calibration and linearity assessment to DOCUMENT Multi-Analyte CAL•VER, DOCUMENT Direct ISE CAL•VER DOCUMENT Iron, Magnesium, Triglyceride CAL.VER, DOCUMENT Ammonia/Ethano CAL. • VER, and Roche Diagnostics Precitrol Ethyl Alcohol/ Ammonia/Lactate Control.
4
Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three abstract shapes that resemble a person.
AUG 2 0 2001
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Christine V. Beach Manager, RA/QA Maine Standards Company, LLC 765 Roosevelt Trail Windham, ME 04062
510(k) Number: K012117 Re: Trade/Device Name: VALIDATE Chem 1 Calibration Verification Test Set Regulation Number: 862.1660 Regulatory Class: Class I, Reserved Product Code: JJY Dated: July 3, 2001 Received: July 6, 2001
Dear Ms. Beach:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
5
Page 2 -
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and 1 additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, ( Sase contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small mionitation on your respons and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Steven Autman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
INDICATIONS FOR USE STATEMENT
510(k) Number: Holall ] | 7 | 2
Device Name: VALIDATE Chem 1 Calibration Verification Test Set
Indications for Use:
The VALIDATE Chem 1 Calibration Verification Test Set is used by trained laboratory professionals for quantitatively verifying calibration, validating reportable ranges, and determining linearity in automated, semi-automated and manual chemistry systems for the following analytes: sodium, potassium, chloride, calcium, phosphorus, lactate, glucose, urea nitrogen, creatinine, triglyceride, ammonia, ethanol, magnesium, and lithium.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use X
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Division Sign-Off)
Division o. nical Laboratory Devices
510(k) Number KC12/17